Chronic hepatitis C: Interferon retreatment of relapsers. A meta-analysis of individual patient data

Relapse after interferon (IFN) therapy for chronic hepatitis C virus (HCV) infection occurs in 50% of patients after the initial response. The benefit of retreatment with IFN alone has not been assessed in large controlled st udies. To assess the effectiveness and the tolerability of IFN retreatment and to identify the optimal second course regimen, we performed a meta-anal ysis of individual patient's data on a set of 549 patients (mean age 43.8 y ears; 12.2 SD, men: 65%) who had an end-of-treatment biochemical response t o a first IFN course and then relapsed. Retreatment was started within 24 m onths after the end of the first course. Biochemical end-of-treatment respo nses (ETR) and sustained responses (SR) were observed in 405 of 549 (73.8%; 95% confidence interval [CI] 70.1-77.5) and in 124 of 549 (22.6%; CI 19.1- 26.1) patients, respectively. One hundred seventy-five of 404 patients (43. 3%; CI 38.6-48.2) developed an end-of-treatment, biochemical, and virologic al response when retreated. A biochemical and virological SR to retreatment occurred in 73 of 494 (14.8%; CI 11.7-18) patients. Thirty-two patients (5 .8%; CI 3.5-7.8) stopped retreatment for adverse effects. Biochemical and v irological SR was predicted independently by logistic regression analysis u sing a negative HCV RNA at the end of the first cycle of IFN (P =.01) and b y retreatment with a high IFN dose (P =.03), Age, cirrhosis, genotype, and gamma-glutamyl transferase levels before retreatment were not significant b y multivariate analysis. The excellent tolerability of IFN monotherapy retr eatment makes it an option for patients who transiently cleared HCV-RNA dur ing their first IFN course. Patients should be retreated with a high IFN do se regardless of the strength of the dose received during the previous cour se of treatment.